NCT04844073 · OUTCOME
t1/2: Terminal Half-Life of TAK-186
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)
What was measured
t1/2 of TAK-186 was reported. As prespecified in the analysis plan, all participants in this combined cohort received the same target dose level of TAK-186. Therefore, data from these participants were pooled and analyzed as a single cohort.
Analysis population: PK population. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure \& "number analyzed" signifies participants at specific categories. No participants in Dose Escalation Phase: TAK-186 - Dose A Arm group attended for t1/2. TAK-186 was administered QW and had a LiD regimen including 1-step and 2-step lead-in. Analysis at the lead-in dose time points was not possible due to insufficient data points.
Groups in this outcome
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone
Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
Participants in Dose Escalation Phase and Cohort Expansion Phase received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
| Group | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 1 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 4 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 9 |
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 56 |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 4 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 10 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 1 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 0 |
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 25.2 | Not reported | 25.2 | 25.2 | Not reported |
Cycle 1 Day 8
| Group | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 4 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 9 |
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 15.3 | Not reported | 13.4 | 17.1 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 12.7 | Not reported | 9.46 | 14.6 | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 0 |
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 56 |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 4 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 14.1 | Not reported | 1.73 | 64.2 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 10.0 | Not reported | 7.22 | 11.6 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 12.7 | Not reported | 9.04 | 18.3 | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 5 |
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 21 |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 2 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 12.4 | Not reported | 7.39 | 18.0 | Not reported |
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 28.3 | Not reported | 1.48 | 56.8 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 46.5 | Not reported | 46.5 | 46.5 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 249 | Not reported | 30.7 | 468 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 25.2
- upper Limit
- 25.2
- value
- 25.2
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG002
- lower Limit
- 13.4
- upper Limit
- 17.1
- value
- 15.3
- group Id
- OG003
- lower Limit
- 9.46
- upper Limit
- 14.6
- value
- 12.7
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG004
- lower Limit
- 1.73
- upper Limit
- 64.2
- value
- 14.1
- group Id
- OG005
- lower Limit
- 7.22
- upper Limit
- 11.6
- value
- 10.0
- group Id
- OG006
- lower Limit
- 9.04
- upper Limit
- 18.3
- value
- 12.7
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 56
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- group Id
- OG003
- lower Limit
- 7.39
- upper Limit
- 18.0
- value
- 12.4
- group Id
- OG004
- lower Limit
- 1.48
- upper Limit
- 56.8
- value
- 28.3
- group Id
- OG005
- lower Limit
- 46.5
- upper Limit
- 46.5
- value
- 46.5
- group Id
- OG006
- lower Limit
- 30.7
- upper Limit
- 468
- value
- 249
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 56
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- units
- Participants
- description
- t1/2 of TAK-186 was reported. As prespecified in the analysis plan, all participants in this combined cohort received the same target dose level of TAK-186. Therefore, data from these participants were pooled and analyzed as a single cohort.
- dispersion Type
- Full Range
- groups
- description
- Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
- id
- OG000
- title
- Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
- description
- Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
- id
- OG001
- title
- Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
- id
- OG002
- title
- Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
- id
- OG003
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
- description
- Participants in Dose Escalation Phase and Cohort Expansion Phase received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
- id
- OG004
- title
- Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
- id
- OG005
- title
- Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
- id
- OG006
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
- param Type
- MEDIAN
- population Description
- PK population. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure \& "number analyzed" signifies participants at specific categories. No participants in Dose Escalation Phase: TAK-186 - Dose A Arm group attended for t1/2. TAK-186 was administered QW and had a LiD regimen including 1-step and 2-step lead-in. Analysis at the lead-in dose time points was not possible due to insufficient data points.
- reporting Status
- POSTED
- time Frame
- Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)
- title
- t1/2: Terminal Half-Life of TAK-186
- type
- SECONDARY
- unit Of Measure
- hours
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Preserved source evidence · Not medical advice
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